US Regulatory Roundup – September 2022: Philips Troubles, Software And User Fees
The ten most popular stories about US regulatory issues published by Medtech Insight last month were a mixed bag, with a Philips recall taking the top spot and stories about AI, user fees, and more adding to the list.
You may also be interested in...
Passed by the US House and signed into law on 30 September, the Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023, avoids a partial government shutdown and furloughs in FDA user-fee programs including MDUFA. Policy riders stripped from the legislation, including for FDA oversight of lab-developed tests, could still find their way into a final FY 2023 spending omnibus.
Medicare coverage of innovative and life-saving devices, drugs and diagnostics were the focus of a 19 September Congressional hearing during which representatives pressed for swifter and more predictable paths to reimbursement.
The US FDA has finalized a guidance document on the Voluntary Improvement Program, which aims to help manufacturers continuously improve quality and compliance.